Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded and your abilities challenged. It is a place where your diversity — of culture, thinking, learning and leading — is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt's mission is to advance health and wellness through preeminent programs in patient care, education, and research.

Monroe Carell Jr. Children's Hospital at Vanderbilt is one of the nation's leading children's hospitals. We treat and help prevent all health issues ranging from colds and broken bones to heart disease and cancer.

The world-class facilities at Children's Hospital are a testament to our community's dedication to the health of children. Constructed in 2004 and expanded in 2012, our 271-bed hospital is a child-friendly place built on the science of healing.

A building alone does not make a great hospital. Our exceptional medical teams and the generous support of people like you enable us to provide every child who comes to us with the hope of improved health. Children's Hospital is a nonprofit facility. No child who needs our services is denied care on the basis of limited ability to pay.

Many of our doctors and surgeons are nationally recognized researchers who are finding new ways to cure and prevent childhood diseases. Their work preventing and treating premature birth, cancer, heart disease, spina bifida, and many other conditions is an investment in the future. We are at an important crossroads in child health. Our commitment to research and advocacy positions us to bring the promise of good health to children and families in our community and to share that hope with the world.

Your Role :

Responsible for the timely preparation, planning and quality control of regulatory documents required for human subjects research. Oversees the preparation and submission of national and international applications and ongoing reports for clinical trials approvals and renewals. Collaborates with all levels of scientific, medical and technical staff to support regulatory strategies, policies and procedures. Interfaces with national and international regulatory agencies and industry sponsors in the approval of Phase I, II, III, and IV clinical studies.

KEY RESPONSIBILITIES:

Regulatory affairs management of clinical research activities.

Establishes working relationships with investigators and research staff to facilitate communication and participation in research start-up procedures.

Works as a part of a project team in the development and design of applications for support of clinical trials.

Interfaces with federal agencies and industry sponsors in the approval of Phase I, II, III, IV clinical research studies.

Participates and provides input in interdepartmental, industry, and international project teams as the regulatory representative interpreting and applying regulations, guidelines, research/information available, and policies to enable the team to select the most effective start up.

Vanderbilt University Medical Center is home to Vanderbilt University Hospital, The Monroe Carell Jr. Children’s Hospital at Vanderbilt, the Vanderbilt Psychiatric Hospital and the Vanderbilt Stallworth Rehabilitation Hospital. These hospitals experienced more than 61,000 inpatient admissions during fiscal year 2015. Vanderbilt’s adult and pediatric clinics treated nearly 2 million patients during this same period.Vanderbilt University Hospital and the Monroe Carell Jr. Children’s Hospital at Vanderbilt are recognized again this year by U.S. News & World Report’s Best Hospitals as among the nation’s best with 18 nationally ranked specialties. Vanderbilt University Medical Center is world renowned because of the innovation, work ethic and collegiality of its employees. From our health care advances to our compassionate care, Vanderbilt owes its accomplishments and reputation to staff and faculty who bring skill and drive and innovation to the medical center day after day. World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.As th...e largest employer in middle Tennessee, we welcome those who are interested in ongoing development in a caring, culturally sensitive and professional atmosphere. Most of us spend so much of our lives at work, we want to be part of maintaining a workplace in which people support one another and encourage reaching for excellence. Many high-achieving employees stay at Vanderbilt because of the professional growth they experience and because of their appreciation of Vanderbilt’s benefits, public events and discussions, athletic opportunities, beautiful setting and, above all, sense of community and purpose.Vanderbilt and its employees share a set of mutual expectations that have been created with productivity, legality, fairness and safety always in mind. We believe that our investment in training and compensating employees multiplies in value when we enable individuals to deliver their best performance for the benefit of us all.